Apply for certificates of free sale for medical devices
Are you responsible for placing a medical device on the market in accordance with Article 5 of Regulation (EU) 2017/745 on medical devices or Regulation (EU) 2017/746 on in vitro diagnostic medical devices and would like to export this to non-EU third countries ? Then the relevant competent authority can issue a certificate in accordance with Section 10 MPDG at your request.
This certificate certifies that the product may be traded in the EU.
Responsible authority
The four regional councils in Baden-Württemberg (Freiburg, Karlsruhe, Stuttgart and Tübingen) are responsible. Local jurisdiction depends on the administrative district in which the manufacturer's or authorised representative's head office is located. For example, the Freiburg regional council is responsible for manufacturers based in Tuttlingen (Freiburg administrative district).
Details
Prerequisite
- Product must be placed on the market in accordance with Article 5 and Article 10 or 11 of Regulation (EU) 2017/745 of a medical device
- Product must be placed on the market in accordance with Article 5 and Article 10 or 11 of Regulation (EU) 2017/746 of an in vitro diagnostic medical device
- Only manufacturers and authorised representatives based in Germany can submit an application for a certificate of free sale for medical devices and in vitro diagnostic medical devices here
Procedure
- You submit your application
- The competent authority checks the documents
- The competent authority requests additional documents if necessary
- The competent authority issues the certificate
Deadlines
The certificate of marketability according to § 10 MPDG confirms the status as of the date of issue. Each recipient country decides on the period of validity of the certificate itself.
Required documents
- Declaration of conformity
- Certificate(s) of the Notified Body(ies)
- Product list
Costs
Cost type: variable
Description of costs: Fee
Note: Medical device law is federal law and is enforced by the respective federal states. Therefore, the respective fee ordinance of the federal state must be applied.
Processing time
Duration: up to 3 weeks
Miscellaneous
The online service is still under construction, please contact the responsible regional council.
Legal basis
Artikel 60 (EU) 2017/745 (MDR)
Artikel 55 (EU) 2017/746 (IVDR)
Medizinprodukterecht-Durchführungsgesetz (MPDG):
- § 10 Freiverkaufszertifikate
Release note
Machine generated, based on the German release by: Sozialministerium Baden-Württemberg, 26.06.2025